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Oral Anti-Infective Agent for Esophageal Anastomotic Leakage

The Correlation of Oral Anti-Infective Agent With Anastomotic Leakage in Reconstruction Surgery for Esophageal Cancer

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00942526
Enrollment
120
Registered
2009-07-21
Start date
2009-06-30
Completion date
2010-12-31
Last updated
2009-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomotic Leakage

Keywords

esophageal cancer, anastomotic leakage, Prevention of anastomotic leakage after esophageal surgery

Brief summary

Anastomotic leakage is still to be a major cause of considerable morbidity and mortality after esophagectomy and gastric pull up for esophageal carcinoma. Risk factor analyses of anastomotic leakage, including blood supply, graft tension, and comorbidity, have been performed, but few studies have produced strategies that have improved operative results. This study will be performed to identify prognostic variables that might be used to develop a strategy for optimizing outcomes after esophagogastrectomy.

Detailed description

Goal: The effect of oral hygiene on the occurrence of esophagogastric anastomotic leakage has not yet been studied for along time. We will use a random cohort study model and investigate the effect of perioperative oral anti-infective gargle agent on the esophagogastric anastomotic wound healing. Method: 1. Design: One hundred and twenty patients are divided into 3 groups and each group has 40 esophageal patients. Minimization stratified randomization will be applied. Oral anti-infective gargling agent, Mycostatin oral suspension, will be employed for one week before operation. The first groups will be treated without oral gargle agent; the second groups will be treated with gargling water; and the third groups will be treated with anti-infective gargling agent. An end-to-side two-layer esophagogastric anastomosis will be constructed using interrupted sutures with metallic staple through cervical wound. On the other hand, the anastomotic leakage rates in different groups will be investigated. 2. Data Collection and Statistic Analysis: The records of all patients, various biologic parameters, and the management of leakage are analyzed. Thirty-day morbidity and mortality are determined, and stepwise multivariable logistic regression analysis assesses the effect of preoperative and postoperative variables on anastomotic leakage. Time variation of starting oral feeding and hospital stay are compared using the Kaplan-Meier method.

Interventions

DRUGMycostatin oral suspension

peroperative Mycostatin oral suspension ( 0.1MU/cc, 24cc/bt; 5cc qid)for 7 days

OTHERWater

perioperative gargling with water

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* carcinoma of the esophagus, operable stage I to III

Exclusion criteria

* patients who were inoperable, * patients who had obvious impaired blood supply of gastric substitutes, and * patients who had non-cervical esophagogastrostomy.

Design outcomes

Primary

MeasureTime frame
all cause anastomotic leakagetwo years

Secondary

MeasureTime frame
Time variation of starting oral feeding and hospital staytwo years

Countries

Taiwan

Contacts

Primary ContactPei-Ming Huang, MD
e370089@gmail.com+886-2-23123456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026